Stakeholders: FDA vacancies will hurt, but agency will weather storm

By Hank Schultz contact

- Last updated on GMT

FDA photo
FDA photo

Related tags: Fda, Regulation, Cbd, hemp extracts, Ndi notifications, Ndi draft guidance

Industry stakeholders say that while critical vacancies at the US Food and Drug Administration come at an awkward time they believe the agency will fulfill its responsibilities.

Two key personnel—Robert Durkin and Sibyl Swift PhD, have left the Office of Dietary Supplement Programs in recent months.  Durkin, an attorney, left for private practice, where he is of counsel with the firm Arnall Golden Gregory.  Durkin had a background in pharmacy and molecular biology before taking his law degree.  At FDA he was most recently the deputy director of ODSP, a post he had held for more than four years. Durkin’s total tenure at FDA spanned more than 11 years.

Swift was most recently associate director of research and strategy at FDA and had also served as a special assistant and program coordinator at ODSP.  Swift, who has a PhD in nutrition and has worked as a research biochemist, spent more than five years at FDA. Swift left to become the senior vice president of scientific and regulatory affairs at the Natural Products Association (NPA).

Growing pressure on FDA on several fronts

FDA is under an unusual amount of pressure at the moment with the rapid growth of the extralegal CBD market.  The 2018 Farm Bill made cultivation of industrial hemp much easier, and many producers have jumped into the game.  Consumer demand and the lower cost of raw materials due to increasing supplies has made for a thriving market.

But it’s one that in FDA’s view still runs counter to the letter of the law.  According to FDA’s reading of DSHEA, the fact that a CBD drug has been investigated and approved prior to CBD products coming to market precludes its legal use in supplements or foods.  

A number of lawmakers, including Senate majority leader Mitch McConnell, (R-KY), have requested that FDA move quickly to resolve this issue and provide a legal pathway to market for CDB products.  The agency convened a meeting last May on the matter and promised a statement on the issue by early fall, but that has yet to happen.

Also on the agency’s plate are questions surrounding what’s to be done about the draft guidance on New Dietary Ingredients as well as the discussion surrounding possible modifications of the Dietary Supplement Health and Education Act, which is the foundational legislation that created the dietary supplement industry as it is known today.

Stakeholders:  Awkward time to be depleted

Industry stakeholders admit that putting that all together, it’s an awkward time for the agency to be down two experienced team members.  And the agency is just integrating a new commissioner, Dr Stephen Hahn, MD, who was confirmed by the Senate in December​.  But ODSP itself has had a leader in Stephen Tave of some tenure, and longtime FDA staffer Cara Welch, PhD (who has also spent time at NPA), has returned to ODSP as deputy director​.

Michael McGuffin, president of the American Herbal Products Association (AHPA), said it’s wise to keep in mind that much of what will affect the dietary supplement industry extends beyond what happens at ODSP itself.

“The ODSP is not going to be the point at which FDA makes its decisions on cannabis, hemp, CBD.  And the FDA is resourceful;  they are good at identifying and attracting talented people,” ​McGuffin told NutraIngredients-USA.

“With that being said, I wouldn’t want to have to fill critical vacancies in a small team,”​ he said.

But Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), said his organization is concerned that the things ODSP is responsible for, such as the NDI issue, will continue to hang fire while the office gets back up to speed.

“I think it is concerning that there has been this level of turnover at ODSP.  Like any organization where there is turnover there is an inevitable slowdown while they replace those personnel,” ​Mister said.

“We need their help in doing things like developing the NDI master files so that companies can have an incentive to submit their NDIs and know that their information can be protected.  And there is the issue of probiotics, labeling in terms of CFUs as opposed to milligram amounts.  And CRN has worked on the issue of certificates of free sale for export. All of these issues require resources and manpower at FDA.  We hope they move quickly to fill these vacancies,”​ he said.

NPA: Losses will hurt, but remaining employees are dedicated

Daniel Fabricant, PhD, NPA president and CEO, who lured Swift away from FDA, said her loss and that of Durkin is bound to hurt in the short term.

“I imagine that it is a critical loss to all of their core functions. Dr Swift  is incredibly dynamic, with a tremendous breadth of knowledge and I’m sure the loss of Durkin has created a number of gaps at ODSP as well. However, FDA and all at ODSP swore an oath to the mission of the agency which is to promote and protect public health and the expectation is that they are fulfilling that oath every day, as it pertains to dietary supplements, independent of the circumstance,” ​he said.

“I think they are under significant pressure, however much of it is self-induced. Take away new regulatory (New Nutrition Facts)  and statutory requirements (FSMA) and its all self-induced. Two big topics  last year, that the agency had public meetings on, one around CBD and one around NDI have not yielded any action by the agency thus far. Don’t get me wrong, meetings are important still, there’s more focus at FDA on having a meeting or getting out an NDI guidance versus dealing with adulterated dietary supplement imports,”​ he said.

“Our members want to be able to say that FDA is getting the job done in a timely manner. Patience on many of the issues is the rate limiting step. Considering that NPA has such a history with the FDA, more so with the addition of Dr. Swift, we certainly believe in their ability to get the job done in accord with their mission and current authorities and we will do all we can to support that,”​ Fabricant added.

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